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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,306 FDA drug recalls.

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DateProductReasonClassFirm
May 21, 2025 Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, C... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Cholin... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 8... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inver... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-fi... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thriv... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Soluti... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thriv... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions,... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 21, 2025 Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverne... Lack of Assurance of Sterility Class II Thrive Health and Wellness, LLC, dba Thrive Hea...
May 15, 2025 BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of... Class II CareFusion 213, LLC
May 2, 2025 Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Mult... Lack of Assurance of Sterility Class II Empower Clinic Services, LLC dba Empower Pharmacy
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulos... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Pro... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodiu... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromello... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 15, 2025 FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0... Lack of Assurance of Sterility Class II Apollo Care, LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Mar 31, 2025 PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mc... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 21, 2025 Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manu... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 7, 2025 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL S... Lack of Assurance of Sterility Class II Exela Pharma Sciences LLC
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Feb 18, 2025 Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, ... Lack of Assurance of Sterility: due to a quality control process deviation. During an internal qu... Class II Turbare Manufacturing
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I CareFusion 213, LLC
Feb 12, 2025 ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. Class II Wuxi Medical lnstrument Factory Co., Ltd.
Feb 10, 2025 Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, ne... Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. Class II Nephron Sterile Compounding Center LLC
Jan 31, 2025 fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single... Lack of Assurance of Sterility Class II Fagron Compounding Services
Dec 19, 2024 phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 19, 2024 ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 18, 2024 Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... Non-Sterility Class I Alcon Research LLC
Dec 10, 2024 PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles,... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Dec 10, 2024 LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distribu... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.